StaphVAX in Cardiovascular Surgery Patients

This study has been completed.

Sponsor:

Information provided by:

Nabi Biopharmaceuticals

ClinicalTrials.gov Identifier:

NCT00211913

First received: September 13, 2005

Last updated: December 26, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 26, 2007

Start Date ^ICMJE

June 2004

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serotype-specific antibody concentrations [ Time Frame: 6 weeks after the vaccine dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Serotype-specific antibody concentrations six weeks after the vaccine dose.

Change History

Complete list of historical versions of study NCT00211913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Serotype-specific antibody concentrations [ Time Frame: at other time points 7-180 days after the vaccine dose. ] [ Designated as safety issue: No ]
adverse events [ Time Frame: 0-180 days after vaccine dose ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Serotype-specific antibody concentrations at other time points after the vaccine dose.
Safety.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

StaphVAX in Cardiovascular Surgery Patients

Official Title ^ICMJE

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Undergoing Cardiovascular Surgery

Brief Summary

S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Staphylococcal Infections
Cardiovascular Diseases
Cardiovascular Surgical Procedures

Intervention ^ICMJE

Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single IM dose totalling 200 mcg of conjugate

Other Name: StaphVAX®
Biological: placebo
single IM dose

Study Arm (s)

Experimental: vaccine
single dose of StaphVAX®

Intervention: Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Placebo Comparator: placebo
single dose

Intervention: Biological: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

January 2006

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Candidate for cardiovascular surgery
Expected to comply with protocol
Negative pregnancy test where appropriate
Written informed consent

Exclusion Criteria:

Known S. aureus infection in past 3 months
Known infection in the past 2 weeks
Known HIV infection
Pregnancy or breast-feeding
Immunomodulatory drugs
Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
investigational drugs, vaccines or products in the past 30 days
Hypersensitivity to components of StaphVAX

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00211913

Other Study ID Numbers ^ICMJE

Nabi-1366

Has Data Monitoring Committee

Responsible Party

Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nai Biopharmaceuticals

Study Sponsor ^ICMJE

Nabi Biopharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Preston Holley, MD

Nabi Biopharmaceuticals

Information Provided By

Nabi Biopharmaceuticals

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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